May 9, 2019· Comment from Association for Accessible Medicines ("AAM")· FDA-2013-D-1543-0248
Comments of the Association for Accessible Medicines and the Biosimilars Council on behalf of our member companies regarding Docket No. FDA-2013-D-1543: Nonproprietary Naming of Biological Products: Update; Draft Guidance for Industry; Availability. The Association for Accessible Medicines (AAM), and its Biosimilars Council (Council) (collectively referred to in these comments as AAM), submit these comments to FDAs updated guidance on Nonproprietary Naming of Biological Products. Please find full comment letter enclosed.